Wednesday, August 18, 2010

FDA to change medical device regulation to shorten approval time

The US Food and Drug Administration (FDA) intends to change regulations for medical device manufacturers in attempt to shorten approval time.

A report by news agency Bloomberg indicated that the FDA released proposed new requirements for the 510(k) program. According to Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, the FDA intends to grant device companies a more predictable process while asking them for additional safety data.

Shuren said device makers will be asked to provide a complete summary of all information about the safety of their products. This will include clinical studies relevant to a product. 

The FDA intends to create a Science Council for its medical device unit to “assure quality and consistency” about “some of the tougher science questions,” Shuren said.

The agency also plans to streamline the application process for a category of devices that aren’t similar to earlier products and are deemed to have a low enough safety risk that human studies aren’t needed, Shuren said. The “de novo” process, a subject of frequent complaints by the device industry, has been plagued by “lengthy review timeframes and nontransparent data requirements,” Shuren said.

The agency expects to begin making the changes later this year after a 60-day public comment period, Shuren said.

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